Rheumatoid Arthritis Clinical Trial
Official title:
A Post-Marketing Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up
Foot silicone implants suffer from bad reputation on the market, due to poor results
obtained with the first generations of implants. Allergies to silicone, infections due to
silicone and implants breakage used to be common with previous generations of silicone
implants. Publications relative to those implants showed that the survival rates after 5
years of follow-up were unsatisfactory.
Since 1998, Tornier has been selling a new generation of silicone implants made of
Ultrasil™. The use of this new material in its manufacturing process together with its
innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting
implant.
The main objective of this study is to evaluate the clinical outcomes of the implantation of
Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in
terms of functional metrics from documented clinical data. Other objectives are to evaluate
the outcomes in terms of radiological evaluation and of safety during all the follow-up.
This is an observational post-marketing surveillance study, performed by 1 (one)
investigator in 1 (one) Italian site.
Preoperative and perioperative data will be collected retrospectively. Data at a minimum of
5 years after the surgery - or until implant revision - will be collected prospectively.
;
Observational Model: Cohort
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